The following data is part of a premarket notification filed by Medical Flow Systems Ltd with the FDA for Smartblock Pain Pump.
| Device ID | K072053 |
| 510k Number | K072053 |
| Device Name: | SMARTBLOCK PAIN PUMP |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | MEDICAL FLOW SYSTEMS LTD 2940 WEST 123RD TERRACE Leawood, KS 66200 |
| Contact | Mark Dollinger |
| Correspondent | Mark Dollinger MEDICAL FLOW SYSTEMS LTD 2940 WEST 123RD TERRACE Leawood, KS 66200 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-26 |
| Decision Date | 2007-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05707480120864 | K072053 | 000 |
| 05707480110971 | K072053 | 000 |
| 05707480110957 | K072053 | 000 |
| 05707480143856 | K072053 | 000 |
| 05707480155897 | K072053 | 000 |
| 05707480155873 | K072053 | 000 |
| 05707480155859 | K072053 | 000 |
| 05707480155811 | K072053 | 000 |
| 05707480155736 | K072053 | 000 |
| 05707480155699 | K072053 | 000 |
| 05707480155675 | K072053 | 000 |
| 05707480155651 | K072053 | 000 |
| 05707480155637 | K072053 | 000 |
| 05707480155613 | K072053 | 000 |
| 05707480110995 | K072053 | 000 |
| 05707480111015 | K072053 | 000 |
| 05707480120840 | K072053 | 000 |
| 05707480120789 | K072053 | 000 |
| 05707480120765 | K072053 | 000 |
| 05707480120703 | K072053 | 000 |
| 05707480120680 | K072053 | 000 |
| 05707480119271 | K072053 | 000 |
| 05707480111534 | K072053 | 000 |
| 05707480111510 | K072053 | 000 |
| 05707480111473 | K072053 | 000 |
| 05707480111459 | K072053 | 000 |
| 05707480111305 | K072053 | 000 |
| 05707480111282 | K072053 | 000 |
| 05707480111039 | K072053 | 000 |
| 05707480155590 | K072053 | 000 |